Efficacy and safety of tigecycline monotherapy compared with vancomycin-aztreonam in the treatment of complicated skin and skin structure infections in patients from India and Taiwan

J Microbiol Immunol Infect. 2011 Apr;44(2):116-24. doi: 10.1016/j.jmii.2010.04.002. Epub 2011 Jan 15.

Abstract

Background: To compare the monotherapy of tigecycline with vancomycin-aztreonam in hospitalized patients from India and Taiwan with complicated skin and skin structure infections (cSSSIs).

Methods: Safety and efficacy data were analyzed for Indian (n = 86) and Taiwanese (n = 41) patients hospitalized with cSSSIs who participated in two international Phase 3, randomized, double-blind studies.

Results: Patients were treated for 5-14 days. Cure rates at the test-of-cure assessment (12-92 days post-therapy) were generally similar between tigecycline and vancomycin-aztreonam in the clinically evaluable populations (India, 83.3% vs. 75.8%; Taiwan, 78.6% vs. 90%) and in the clinical modified intent-to-treat populations (India, 78.6% vs. 66.7%; Taiwan, 73.3% vs. 75.0%). Nausea and vomiting occurred more frequently with tigecycline, but overall safety and tolerability were comparable between the two treatments.

Conclusions: Tigecycline monotherapy is a safe and effective therapy for cSSSIs in geographically distinct populations in Asia.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Aztreonam / adverse effects
  • Aztreonam / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • India
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Minocycline / adverse effects
  • Minocycline / analogs & derivatives*
  • Minocycline / therapeutic use
  • Nausea / etiology
  • Skin Diseases, Bacterial / drug therapy*
  • Taiwan
  • Tigecycline
  • Vancomycin / adverse effects
  • Vancomycin / therapeutic use*
  • Vomiting / etiology

Substances

  • Anti-Bacterial Agents
  • Vancomycin
  • Tigecycline
  • Minocycline
  • Aztreonam